Effect of Osteopathic Lymphatic Treatment on Plasma Volume, Protein Concentration and Albumin Concentration.
This study has been completed.
Sponsor:
Kansas City University of Medicine and Biosciences
Information provided by:
Kansas City University of Medicine and Biosciences
ClinicalTrials.gov Identifier:
NCT00742989
First received: August 26, 2008
Last updated: August 27, 2008
Last verified: August 2008
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Purpose
The goal of this project is to see how much an osteopathic lymphatic treatment (OLT) causes an increase in plasma volume, total plasma protein concentration, and albumin concentration. This is an important step in understanding the effects of OLT, specifically its effects on fluid in the body. The primary role of the lymph system is the return of fluid and proteins lost from the blood vessels. Despite this, no research has been done to see what effects an OLT has on fluid and protein levels in the blood.
| Condition | Intervention |
|---|---|
|
Healthy Volunteers |
Other: OLT maneuver Other: Sham OLT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | The Short-Term Effect of Osteopathic Lymphatic Treatment on Blood Cell Count, Plasma Protein, and Blood Pressure: A Pilot Study in a Cross-Over Design |
Further study details as provided by Kansas City University of Medicine and Biosciences:
Primary Outcome Measures:
- Baseline blood pressure [ Time Frame: 15 minute ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Plasma proteins [ Time Frame: 15 minute ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | May 2005 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
OLT administration
|
Other: OLT maneuver
direct myofascial release for the thoracic inlet for 30 seconds, supine rib raising for 1 minute on each side of the body, thoracic pumping for one minute, thoracic vacuum for 30 seconds, doming of the abdominal diaphragm for 30 seconds, abdominal pumping for 1 minute, pedal pumping for 1 minute, a second thoracic pump for 1 minute, a second thoracic vacuum for 30 seconds, and a final direct myofascial release for the thoracic inlet lasting 30 seconds
|
|
Sham Comparator: B
placebo-OLT
|
Other: Sham OLT
Therapeutic massage performed
|
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Normal, healthy volunteers
- Males
- Age 20 to 40 years
Exclusion Criteria:
- History of cardiovascular, kidney, or liver disease.
- Cannot have taken medication or drugs or have been ill at the time of the study or for two weeks prior.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742989
Locations
| United States, Missouri | |
| Dybedal Clinical Research Center, Kansas City University of Medicine and Biosciences | |
| Kansas City, Missouri, United States, 64106 | |
Sponsors and Collaborators
Kansas City University of Medicine and Biosciences
Investigators
| Principal Investigator: | W. Evan Rivers, DO | Kansas City University of Medicine and Biosciences |
| Study Director: | Charlott L. Williiams, RN, CCRC | Kansas City University of Medicine and Biosciences |
| Study Director: | Alan G. Glaros, PhD | KCUMB |
| Study Chair: | Kevin Treffer, DO | KCUMB |
More Information
Additional Information:
No publications provided by Kansas City University of Medicine and Biosciences
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Patrick G. Clay, PharmD, Director, Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences |
| ClinicalTrials.gov Identifier: | NCT00742989 History of Changes |
| Other Study ID Numbers: | KCUMB-2005-01 |
| Study First Received: | August 26, 2008 |
| Last Updated: | August 27, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kansas City University of Medicine and Biosciences:
|
osteopathic lymphatic treatment OLT normal |
ClinicalTrials.gov processed this record on May 19, 2013